Trial Outcomes & Findings for Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study (NCT NCT05135650)

Last Updated: 2025-02-13

Results Overview

Will use descriptive statistics of model estimation from population pharmacokinetic model. Levels of VIR-7831 can be measured using an idiotypic antibody assay that is not affected by COVID-19 infection or vaccination.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Up to 24 weeks

Results posted on

2025-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Sotrovimab Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sotrovimab n=20 Participants Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Diagnosis Acute leukemia	5 Participants n=5 Participants
Diagnosis T-LGL	1 Participants n=5 Participants
Diagnosis MDS	5 Participants n=5 Participants
Diagnosis MPN (CMML, MF)	3 Participants n=5 Participants
Diagnosis Lymphoma	3 Participants n=5 Participants
Diagnosis Multiple myeloma	3 Participants n=5 Participants
Conditioning regimen Mel	3 Participants n=5 Participants
Conditioning regimen Flu/Mel	2 Participants n=5 Participants
Conditioning regimen Flu/Treo	1 Participants n=5 Participants
Conditioning regimen Flu/TBI	3 Participants n=5 Participants
Conditioning regimen Bu/Cy	1 Participants n=5 Participants
Conditioning regimen Flu/Mel/TBI	5 Participants n=5 Participants
Conditioning regimen Flu/Cy/TBI	1 Participants n=5 Participants
Conditioning regimen Bu/Cy/Thiotepa	1 Participants n=5 Participants
Conditioning regimen Bu/Cy/Thiotepa/Palifermin	1 Participants n=5 Participants
Conditioning regimen Flu/Cy/Thiotepa/TBI	1 Participants n=5 Participants
Conditioning regimen CLAG-M/TBI	1 Participants n=5 Participants
Type of transplant Allogeneic matched unrelated	8 Participants n=5 Participants
Type of transplant Allogeneic matched related	4 Participants n=5 Participants
Type of transplant Allogeneic mismatched unrelated	1 Participants n=5 Participants
Type of transplant Allogeneic cord blood	2 Participants n=5 Participants
Type of transplant Autologous	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Outcome measures

Outcome measures
Measure	Sotrovimab n=20 Participants Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.	TASSO Device Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample via self-collected TASSO device, and nasal swab collections throughout course of trial.
Half-life of Sotrovimab (VIR-7831) Post-transplant	51.14 Days Standard Deviation 18.59	—

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: Neutralization assays were not performed, thus no data was collected.

Will be calculated by a one-phase exponential decay model. Will compare fold-changes in antibody titers by normalizing to pre-transplant levels for each subject. Data analysis was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: There was only 1 participant in the mismatched group, therefore, sample size was too small to calculate and compare mean or median half-lives between groups. Thus, half-life data was not collected on these groups.

Comparisons will be tested using a t-test. Levels of VIR-7831 can be measured using an idiotypic antibody assay that is not affected by COVID-19 infection or vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Two different groups were analyzed based on transplant type. The number of participants in each subgroup will add up to the total number of participants analyzed.

Comparisons will be tested using a t-test. Levels of VIR-7831 can be measured using an idiotypic antibody assay that is not affected by COVID-19 infection or vaccination.

Outcome measures

Outcome measures
Measure	Sotrovimab n=20 Participants Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.	TASSO Device Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample via self-collected TASSO device, and nasal swab collections throughout course of trial.
Half-life of VIR-7831 in Autologous vs Allogeneic HCT Half-life in autologous participants	63.9 Days Interval 51.5 to 75.0	—
Half-life of VIR-7831 in Autologous vs Allogeneic HCT Half-life in allogeneic participants	49.4 Days Interval 19.5 to 69.7	—

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Three different groups were analyzed based on transplant type and presence of diarrhea. The number of patients in each subgroup will add up to the total number of patients analyzed.

Sotrovimab exposure to be measured as the area under curve (AUC) of sotrovimab concentration over time in model simulation. Comparisons will be tested using a t-test.

Outcome measures

Outcome measures
Measure	Sotrovimab n=20 Participants Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.	TASSO Device Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample via self-collected TASSO device, and nasal swab collections throughout course of trial.
VIR-7831 Exposure in Patients With Diarrhea vs no Diarrhea Allogeneic HCT with diarrhea	2027.48 (AUC) micrograms x day/mL Standard Deviation 348.84	—
VIR-7831 Exposure in Patients With Diarrhea vs no Diarrhea Allogeneic HCT without diarrhea	3613.94 (AUC) micrograms x day/mL Standard Deviation 392.81	—
VIR-7831 Exposure in Patients With Diarrhea vs no Diarrhea Autologous HCT without diarrhea	4146.8 (AUC) micrograms x day/mL Standard Deviation 397.57	—

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Three different groups were analyzed based on transplant type and presence of lower GI GVHD. The number of patients in each subgroup will add up to the total number of patients analyzed.

Sotrovimab exposure to be measured as the area under curve (AUC) of sotrovimab concentration over time. Comparisons will be tested using a t-test.

Outcome measures

Outcome measures
Measure	Sotrovimab n=20 Participants Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.	TASSO Device Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample via self-collected TASSO device, and nasal swab collections throughout course of trial.
VIR-7831 Exposure in Patients With and Without Graft Versus Host Disease Allogeneic HCT with lower GI GVHD	1846.97 (AUC) micrograms x day/mL Standard Deviation 315.84	—
VIR-7831 Exposure in Patients With and Without Graft Versus Host Disease Allogeneic HCT without lower GI GVHD	3613.94 (AUC) micrograms x day/mL Standard Deviation 392.81	—
VIR-7831 Exposure in Patients With and Without Graft Versus Host Disease Autologous HCT without lower GI GVHD	4146.8 (AUC) micrograms x day/mL Standard Deviation 397.57	—

SECONDARY outcome

Timeframe: Up to 24 weeks

Will monitor for breakthrough SARS-CoV-2 infection by polymerase chain reaction of fluid collected by nasal swabs.

Outcome measures

Outcome measures
Measure	Sotrovimab n=20 Participants Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.	TASSO Device Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample via self-collected TASSO device, and nasal swab collections throughout course of trial.
Number of Participants With Breakthrough SARS-CoV-2 Acquisition	3 Participants	—

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Only those participants with data available at the specified time points were analyzed. Due to early termination, we did not analyze TASSO samples or nasal swabs, hence there is no TASSO or nasal swab data to report. Two different groups were analyzed based on transplant type. The number of patients in each subgroup will add up to the total number of patients analyzed.

Will compare antibody levels from serum/plasma collected by venipuncture versus self-collected using a TASSO device and fluid from nasal swabs. To do this, will compare rate of antibody clearance on average in study population pharmacokinetic model.

Outcome measures

Outcome measures
Measure	Sotrovimab n=20 Participants Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.	TASSO Device Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample via self-collected TASSO device, and nasal swab collections throughout course of trial.
Antibody Clearance Rate From Serum/Plasma Elimination clearance in autologous HCT participants	0.1074 L/day Standard Deviation 0.0141	—
Antibody Clearance Rate From Serum/Plasma Elimination clearance in allogeneic HCT participants	0.1462 L/day Standard Deviation 0.0479	—

SECONDARY outcome

Timeframe: At 4 and 24 weeks

Population: Only blood collected by venipuncture was assessed. Blood was rarely collected using the TASSO device due to participants declining TASSO use, sotrovimab deauthorization, and early study termination. Limited blood collection with TASSO device, premature study closure, and lack of funds prevented planned laboratory assays on blood collected with the TASSO device. Thus, no laboratory data is available from TASSO-collected blood and no analysis was performed. Further data collection is not planned.

Will monitor for presence of anti-drug antibodies from serum/plasma collected by venipuncture versus self-collected using a TASSO device. Samples were considered either positive or negative for presence of anti-drug antibodies.

Outcome measures

Outcome measures
Measure	Sotrovimab n=19 Participants Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.	TASSO Device Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample via self-collected TASSO device, and nasal swab collections throughout course of trial.
Number of Participants With Presence of Anti-drug Antibodies From Serum/Plasma Baseline with positive test results	0 Participants	—
Number of Participants With Presence of Anti-drug Antibodies From Serum/Plasma Week 4 with positive test results	0 Participants	—
Number of Participants With Presence of Anti-drug Antibodies From Serum/Plasma Week 24 with positive test results	0 Participants	—

SECONDARY outcome

Timeframe: Up to 40 weeks

Will monitor safety with routine labs as part of standard post-transplant care.

Outcome measures

Outcome measures
Measure	Sotrovimab n=20 Participants Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.	TASSO Device Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample via self-collected TASSO device, and nasal swab collections throughout course of trial.
Number of Participants With Adverse Events	4 Participants	—

Adverse Events

Sotrovimab

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Sotrovimab n=20 participants at risk Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.
Gastrointestinal disorders Death	5.0% 1/20 • Number of events 1 • 10 months

Other adverse events

Other adverse events
Measure	Sotrovimab n=20 participants at risk Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients complete questionnaires, blood sample, and nasal swab collections throughout course of trial.
Cardiac disorders Hypertension stage 2	10.0% 2/20 • Number of events 2 • 10 months
Injury, poisoning and procedural complications Tingling	5.0% 1/20 • Number of events 1 • 10 months

Additional Information

Dr. Alpana Waghmare (Study Principal Investigator)

Fred Hutch/University of Washington Cancer Consortium

Phone: 206-667-7329

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place